Device Recall Accu2i pMTA Applicator

  • Model / Serial
    Lots: 15310412, 15330419, 15340427, 15390446, 15430455, 15440461, 15450463, 15480473, 15490478, 16030490, 16060498, 16130514, 16160524, 16180531, 16240552, 16260560, 16330578, 16350585, 16380593, 16400600, 16420605, 16430609, 16440614, 16460621, 16500638, 16510642, 17010647, 17020650, 17030655, 17050661, 17060664, 17080669, 17110676.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots: 15310411, 15320416, 15340428, 15350430, 15360434, 15380439, 15400449, 15420453, 15430454, 15440459, 15460466, 15470468, 15490476, 15500480, 15520487, 16010488, 16050494, 16070499, 16080502, 16100508, 16120512, 16140517, 16150520, 16170528, 16180530, 16190535, 16210540, 16230549, 16240550, 16250556, 16260561, 16270562, 16300568, 16310572, 16320573, 16350581, 16370590, 16380592, 16390595, 16400599, 16410603, 16420604, 16440611, 16450617, 17010645, 17020649, 17030653, 17040657, 17060662, 17070666, 17090673, 17100675, 17130686*, 17130687.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
  • Model / Serial
    Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 16070501, 16130515, 16160525, 16190536, 16250558, 16320574, 16330579,  16420606, 16440612, 16460620, 16480630, 16500637, 17010646,  17030654, 17040659, 17070667, 17090672.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
  • Model / Serial
    Lots: 15310413, 15320415, 15340429, 15350431, 15360432, 15370435, 15380440, 15390444, 15400450, 15430456, 15440460, 15460467, 15470469, 15480471, 15490477, 15500481, 15520484, 16010489, 16050495, 16070500, 16080503, 16090506, 16100509, 16120513, 16150521, 16160523, 16170529, 16190534, 16230548, 16240551, 16250557, 16270563, 16300569, 16310571, 16320575, 16330577, 16350582, 16350586, 16370591, 16390596, 16410602, 16430610, 16440613, 16450618, 16460619, 16500636, 16510644, 17020651, 17040658, 17050660, 17060663, 17070668, 17100674, 17110678,  17130685.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
  • Model / Serial
    Lots: 15330421, 15340426, 15370438, 15390447, 15400452, 15430458, 15440462, 15450465, 15480475, 15500482, 15520486, 16060497, 16100507, 16130516, 16140519, 16160526, 16180532, 16190537, 16240553, 16330580, 16350583, 16380594, 16410601, 16420607,  16430608, 16440616, 16460623, 16480629, 16500639, 17020652, 17090671, 17140694.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
  • Model / Serial
    Lots: 15330420, 15370436, 15390448, 15430457, 15450464, 15480474, 15490479, 15520485, 16030491, 16140518, 16160527, 16180533, 16300570, 16320576, 16350584, 16440615, 16460622, 16480628, 16500640, 16510643, 17010648, 17030656.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer